Therapeutic delivery device

Abstract

A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.

What is claimed is: 
     
       1. A therapeutic delivery device comprising:
 a body defining an internal reservoir for a therapeutic agent and configured to be deployed subcutaneously near a surgical site, the body including a first membrane for controlled release of the therapeutic agent to the surgical site; 
 a port including a stem, the port in fluid communication with the reservoir and being configured such that a user can refill the reservoir via the port; and 
 a sleeve configured to encapsulate the body, the sleeve including a tab region configured to receive one or more fastener to anchor the body in position relative to the surgical site, the sleeve including a second membrane to deliver the therapeutic agent from the body to the surgical site; 
 a drawstring encircling the sleeve; wherein the stem has a dual lumen, wherein a first lumen is in communication with the reservoir and a second lumen receives the drawstring that extends percutaneously from the body to the surrounding environment. 
 
     
     
       2. The therapeutic delivery device according to  claim 1 , wherein the access point of the port is needleless. 
     
     
       3. The therapeutic delivery device according to  claim 1 , wherein the port is configured to extend percutaneously from the body to the surrounding environment. 
     
     
       4. The therapeutic delivery device according to  claim 1 , wherein the port is configured to be deployed subdermally such that a user can refill the reservoir via the port. 
     
     
       5. The therapeutic delivery device according to  claim 1 , wherein the first membrane comprises a polyurethane film. 
     
     
       6. The therapeutic delivery device according to  claim 1 , wherein the tab region includes a hole or a slit and a drawstring that is pulled through all the holes or the slits of the sleeve allowing the therapeutic device to be untethered from the one or more fasteners thereby allowing the therapeutic device to be removed from the surgical site.